Find quality systems engineer Jobs in galway, g

Senior Quality System Engineer
Haemonetics Corp. —Galway, County Galway
- Full-time
- Engineering
- No degree
- Mentoring
Senior Systems Engineer
MBRYONICS —Galway, County Galway
- Full-time
- System design
- Scripting
- Agile
Software Engineer - Apps
Cisco Systems —Galway, County Galway
- Full-time
- Hybrid work
- DevOps
- Windows
- Java
Senior Realibility Engineer
Medtronic —Galway, County Galway
- €64,640–€96,960 a year
- Full-time
- Engineering
- Project management
- Communication skills
1d
Senior Software Engineer-Typescript
Liberty Information Technology —Galway, County Galway
- Full-time
- Hybrid work
- Computer Science
- AWS
- Software development
- Employee discount
Supplier Engineer III
Boston Scientific —Galway, County Galway
- Engineering
- Analysis skills
- Bachelor's degree
10d
Senior Embedded Software Engineer
MBRYONICS —Galway, County Galway
- Full-time
- Master's degree
- Analysis skills
- C++
8d
Trainee Equipment Maintenance Technician
Celestica —Galway, County Galway
- €36,000–€42,000 a year
- No degree
- Communication skills
10d
Manufacturing Engineer II
Merit Medical Systems Inc. —Galway, County Galway
- Full-time
- Word processing
- Engineering
- Analysis skills
- Free parking
Electronics Technician
MBRYONICS —Galway, County Galway
- Full-time
- Manufacturing
- Leadership
- Communication skills
User Experience (UX) Director - Coronary & Renal Denervation (CRDN)
Medtronic —Galway, County Galway
- €124,800–€187,200 a year
- Full-time
- System design
- Master's degree
- Bachelor's degree
Principal Mixed-Signal Hardware Engineer
Medtronic —Galway, County Galway
- €81,120–€121,680 a year
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
Digital Product Lead (Engineering Program Director) Coronary and Renal Denervation CRDN
Medtronic —Galway, County Galway
- €124,800–€187,200 a year
- Full-time
- Computer Science
- Engineering
- Master's degree
Process Engineer
MBRYONICS —Galway, County Galway
- Full-time
- AutoCAD
- ERP systems
- Analysis skills
Process Development Engineer
ICS Medical Devices —Galway, County Galway
- Full-time
- Bachelor's degree
- Continuous improvement
- Manufacturing
- Sick pay
Quick apply
QA Engineer
ICS Medical Devices —Galway, County Galway
- Full-time
- Engineering
- Microsoft Office
- Continuous improvement
- Sick pay
Quick apply
Design Assurance Engineer II (Parkmore Galway)
Integer Holdings Corporation —Galway, County Galway
- Full-time
- Engineering
- Project management
Quick apply
Senior Software Developer (Angular/ C#)
SOTI Inc. —Galway, County Galway
- Full-time
- Computer Science
- Maths
- Bachelor's degree
Software Engineer - MLOps
Liberty IT —Galway, County Galway
- Hybrid work
- AWS
- IT
- SDLC
- Employee discount
Senior Software Cloud Engineer - PCS - IoT
Medtronic —Galway, County Galway
- €65,600–€98,400 a year
- Full-time
- Azure
- Computer Science
- DevOps

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Senior Quality System Engineer

Haemonetics Corp. -
Galway, County Galway

Apply Now

Job details

Full-time

Qualifications

Engineering
Mentoring
Quality systems
ISO 13485

Full job description

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

About the Role / Job Description

We are looking for a Senior Quality Systems Engineer to join our team in Galway, supporting a growing medical device business as it transitions from a start-up environment into a scaled, high-volume operation.

This is a hands-on role where you will take ownership of the site Quality Management System, ensuring it remains compliant, effective, and fit for purpose. In parallel, you will play a key role in the integration of a global QMS following acquisition, helping to align ways of working while maintaining the agility and strengths of the existing site.

You’ll work closely with both local teams and global stakeholders, with real opportunity to influence how quality systems evolve on site.

Essential Duties

Ownership of the site QMS, ensuring ongoing compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR
Lead and support core QMS processes including:
- CAPA
- Change Control
- Nonconformance Management
- Document Control
- Internal Audits
- Management Review
Maintain a state of audit readiness, supporting notified body and regulatory inspections
Act as a go-to QMS subject matter expert on site
Support and lead elements of the integration of the acquiring company’s global QMS
Carry out practical gap assessments and help define how best to align systems and processes
Develop and execute clear, phased integration plans, with a focus on maintaining compliance and minimising disruption to operations
Work with global teams to harmonize procedures and systems, while ensuring they are workable at site level
Apply risk-based thinking to QMS updates and integration activities
Partner with Operations, R&D, Regulatory, and Supply Chain to ensure QMS processes are understood and effectively applied
Provide day-to-day support and development to direct report(s)
Contribute to building a strong quality culture across the site
Identify opportunities to simplify and improve QMS processes, particularly as the site scales

Qualifications

Education

Degree in Engineering, Science, or a related discipline

Experience

5+ years’ experience in a Quality role within the medical device industry
- Strong working knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR
Experience maintaining and improving a practical, working QMS in a manufacturing environment
Exposure to QMS integration, harmonization, or significant change activities would be a strong advantage
Previous experience mentoring or supporting engineers is desirable

Skills / Strengths

Practical, hands-on approach to quality systems
Strong understanding of how QMS works in a real manufacturing environment
Ability to balance compliance requirements with operational realities
Good communicator, comfortable working across functions and levels
Organized, with a focus on delivering clear, workable solutions
Problem Solving
Highly thorough and dependable
Independent in task execution. Meticulous, focus and attentive to details and accuracy in all aspect of the job
Positive attitude, able to influence and lead different groups of employee, motivate and guide people towards organizational success
Analytical minded, resourceful, statistical based decision, data driven direction, use quality tools and methodology in delivering results

Training/Certifications

International standards: ISO13485, ISO19011, ISO14971

Regulatory laws: 21CFR820, 21CFR11, 21CFR803, GDPMD, Malaysia Medical Device Act 2012, Canadian MDR, EU Directive 2007/47/EC, MHLW Ord. 169, Medical Device Single Audit Program (MDSAP), EU Medical Device Regulation (EU MDR 2017/745).

Physical Demand

Sit; use hands to finger, handle, or feel objects, tools, or controls.
Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
Lifting/moving up to 10 pounds.
Exposure to moving mechanical parts, vibration and/or moderate noise levels.
Exposure to hazardous chemicals or other materials.

EEO Policy Statement

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Refine Your Search

quality systems engineer jobs in galway, g

Senior Quality System Engineer

Senior Systems Engineer

Software Engineer - Apps

Senior Realibility Engineer

Senior Software Engineer-Typescript

Supplier Engineer III

Senior Embedded Software Engineer

Trainee Equipment Maintenance Technician

Manufacturing Engineer II

Electronics Technician

User Experience (UX) Director - Coronary & Renal Denervation (CRDN)

Principal Mixed-Signal Hardware Engineer

Digital Product Lead (Engineering Program Director) Coronary and Renal Denervation CRDN

Process Engineer

Process Development Engineer

QA Engineer

Design Assurance Engineer II (Parkmore Galway)

Senior Software Developer (Angular/ C#)

Software Engineer - MLOps

Senior Software Cloud Engineer - PCS - IoT

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